{"protocolSection":{"identificationModule":{"nctId":"NCT05110794","orgStudyIdInfo":{"id":"18277"},"secondaryIdInfos":[{"id":"J2A-MC-GZGJ","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Multiple-Dose Study of LY3502970 in Healthy Participants","officialTitle":"A Phase 1 Multiple Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of LY3502970 in Fed and Fasted Healthy Participants"},"statusModule":{"statusVerifiedDate":"2026-04-15","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-11-05","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-02-10","type":"ACTUAL"},"completionDateStruct":{"date":"2022-02-10","type":"ACTUAL"},"studyFirstSubmitDate":"2021-10-28","studyFirstSubmitQcDate":"2021-10-28","studyFirstPostDateStruct":{"date":"2021-11-08","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-04-30","resultsFirstSubmitQcDate":"2026-04-30","resultsFirstPostDateStruct":{"date":"2026-05-26","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-04-30","lastUpdatePostDateStruct":{"date":"2026-05-26","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The main purpose of this study is to conduct blood tests to measure how much LY3502970 is in the bloodstream and how the body handles and eliminates LY3502970 in healthy participants in fed and fasted states. The study will also evaluate the safety and tolerability of LY3502970 in these participants. The study will last up to 49 days excluding the screening period."},"conditionsModule":{"conditions":["Healthy"],"keywords":["Food","Food Effect"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":34,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"LY3502970 Titration","type":"EXPERIMENTAL","description":"Dose Titration Period: Participants received increasing doses of LY3502970 administered orally every 7 days on Day 1 to Day 21.\n\nDay 1 to Day 8: 2 milligram (mg) LY3502970 every day (QD), Day 8 to Day 15: 4 mg LY3502970 QD, Day 15 to Day 21: 8 mg LY3502970 QD,\n\nParticipants were randomized to Fasted state or Fed state sequence on Day 22.","interventionNames":["Drug: LY3502970"]},{"label":"LY3502970 (Fasted/Fed)","type":"EXPERIMENTAL","description":"Test Period 1: Participants received 16 mg LY3502970 administered orally QD, Day 22 to Day 28 in Fasted state.\n\nTest Period 2: Participants received 16 mg LY3502970 administered orally QD, Day 29 to Day 35 in Fed state.","interventionNames":["Drug: LY3502970"]},{"label":"LY3502970 (Fed/Fasted)","type":"EXPERIMENTAL","description":"Test Period 1: Participants received 16 mg LY3502970 administered orally QD, Day 22 to Day 28 in Fed state.\n\nTest Period 2: Participants received 16 mg LY3502970 administered orally QD, Day 29 to Day 35 in Fasted state.","interventionNames":["Drug: LY3502970"]}],"interventions":[{"type":"DRUG","name":"LY3502970","description":"Administered Orally.","armGroupLabels":["LY3502970 (Fasted/Fed)","LY3502970 (Fed/Fasted)","LY3502970 Titration"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"PK: Maximum Observed Concentration (Cmax) of LY3502970","description":"PK: Cmax of LY3502970.","timeFrame":"PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)"},{"measure":"PK: Area Under the Concentration-time Curve From 0 to 24 Hour (AUC0-24) of LY3502970","description":"PK: AUC0-24 of LY3502970.","timeFrame":"PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)"},{"measure":"Time to Maximum Observed Concentration (Tmax) of LY3502970","description":"PK: Tmax of LY3502970","timeFrame":"PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Are overtly healthy as determined by medical evaluation.\n* Participants with body weight of 45 kilograms (kg) or more and body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m²).\n\nExclusion Criteria:\n\n* Participants who have an abnormal blood pressure and/or pulse rate, deemed to be clinically significant by the investigator at screening.\n* Participants who used or intend to use over-the-counter (OTC) or prescription medication and/or herbal/vitamin/traditional medicines or mineral supplements that may affect the safety or objectives of the study, within 14 days prior to dosing and for the duration of the study. Paracetamol and Covid-19 vaccinations are permitted.\n* Participants who are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study.\n* Participants who show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies. A negative test within 6 months of screening would not need to be repeated.\n* Participants who show evidence of hepatitis C and/or positive hepatitis C antibody. A negative test within 6 months of screening would not need to be repeated.\n* Participants who show evidence of hepatitis B, positive hepatitis B surface antigen, and/or positive hepatitis B core antibody. A negative test within 6 months of screening would not need to be repeated.","healthyVolunteers":true,"sex":"ALL","minimumAge":"21 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Lilly Centre for Clinical Pharmacology","city":"Singapore","zip":"138623","country":"Singapore","geoPoint":{"lat":1.28967,"lon":103.85007}}]},"referencesModule":{"references":[{"pmid":"38402332","type":"DERIVED","citation":"Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. doi: 10.1007/s13300-024-01554-1. Epub 2024 Feb 24."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"During the titration period, participants received increasing doses of LY3502970 administered orally every 7 days on Day 1 to Day 21. Upon completion of the titration period, participants were randomized to Fasted state or Fed state sequence of Day 22.","groups":[{"id":"FG000","title":"2 Milligram (mg)/4 mg/8 mg LY3502970","description":"Dose Titration Period: Participants received increasing doses (2 mg, 4 mg, 8 mg) of LY3502970 administered orally every 7 days on Day 1 to Day 21. Participants were randomized to Fasted/Fed state sequence on Day 22."},{"id":"FG001","title":"16 mg LY3502970 (Fasted/Fed)","description":"Test Period 1: Participants received 16 mg LY3502970 administered orally every day (QD), Day 22 to Day 28 in Fasted state.\n\nTest Period 2: Participants received 16 mg LY3502970 administered orally QD, Day 29 to Day 35 in Fed state."},{"id":"FG002","title":"16 mg LY3502970 (Fed/Fasted)","description":"Test Period 1: Participants received 16 mg LY3502970 administered orally QD, Day 22 to Day 28 in Fed state.\n\nTest Period 2: Participants received 16 mg LY3502970 administered orally QD, Day 29 to Day 35 in Fasted state."}],"periods":[{"title":"Titration Period","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"34"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]},{"title":"Test Period 1","milestones":[{"type":"STARTED","comment":"Upon completion of the Titration Period, participants were randomized to receive study intervention under 2 administration conditions (fed state or fasted state) in Test Period 1 (Days 22 to 28). On Day 29, participants crossed over to the other administration condition in Test Period 2 (Days 29 to 35).","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"15"},{"groupId":"FG002","numSubjects":"14"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"15"},{"groupId":"FG002","numSubjects":"14"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"13"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]}]},{"title":"Test Period 2","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"13"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"13"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"13"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All enrolled participants.","groups":[{"id":"BG000","title":"2 mg/4 mg/8/ mg LY3502970","description":"Dose Titration Period: Participants received increasing doses (2 mg, 4 mg, 8 mg) of LY3502970 administered orally every 7 days on Day 1 to Day 21. Participants were randomized to Fasted/Fed state sequence on Day 22."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"34"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"42.8","spread":"10.2"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"4"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"30"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"34"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"title":"Singapore","categories":[{"measurements":[{"groupId":"BG000","value":"34"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"PK: Maximum Observed Concentration (Cmax) of LY3502970","description":"PK: Cmax of LY3502970.","populationDescription":"All participants who received LY3502970 in fed and fasted state and had evaluable PK samples, per protocol.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanograms per milliliter (ng/mL)","timeFrame":"PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)","groups":[{"id":"OG000","title":"16 mg LY3502970 (Fasted)","description":"Participants received 16 mg LY3502970 administered orally QD, in the fasted state."},{"id":"OG001","title":"16 mg LY3502970 (Fed)","description":"Participants received 16 mg LY3502970 administered orally QD, in Fed state."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"25"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"80.5","spread":"64"},{"groupId":"OG001","value":"67.5","spread":"40"}]}]}]},{"type":"PRIMARY","title":"PK: Area Under the Concentration-time Curve From 0 to 24 Hour (AUC0-24) of LY3502970","description":"PK: AUC0-24 of LY3502970.","populationDescription":"All participants who received LY3502970 in fed and fasted state and had evaluable PK samples, per protocol.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng*hour(h)/mL","timeFrame":"PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)","groups":[{"id":"OG000","title":"16 mg LY3502970 (Fasted)","description":"Participants received 16 mg LY3502970 administered orally QD, in the fasted state."},{"id":"OG001","title":"16 mg LY3502970 (Fed)","description":"Participants received 16 mg LY3502970 administered orally QD, in Fed state."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"25"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1200","spread":"58"},{"groupId":"OG001","value":"1050","spread":"40"}]}]}]},{"type":"PRIMARY","title":"Time to Maximum Observed Concentration (Tmax) of LY3502970","description":"PK: Tmax of LY3502970","populationDescription":"All participants who received LY3502970 in fed and fasted state and had evaluable PK samples, per protocol.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"hour","timeFrame":"PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)","groups":[{"id":"OG000","title":"16 mg LY3502970 (Fasted)","description":"Participants received 16 mg LY3502970 administered orally QD, in the fasted state."},{"id":"OG001","title":"16 mg LY3502970 (Fed)","description":"Participants received 16 mg LY3502970 administered orally QD, in Fed state."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"25"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8.0","lowerLimit":"4.00","upperLimit":"16.00"},{"groupId":"OG001","value":"8.00","lowerLimit":"4.00","upperLimit":"24.00"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"3","timeFrame":"Baseline up to Day 49","description":"All participants who are exposed to study intervention LY3502970. Participants will be analyzed according to the intervention they actually received.","eventGroups":[{"id":"EG000","title":"2 Milligram (mg) LY3502970 QD","description":"2 mg LY3502970 administered orally every day (QD), Day 1 to Day 8.","deathsNumAffected":0,"deathsNumAtRisk":33,"seriousNumAffected":0,"seriousNumAtRisk":33,"otherNumAffected":27,"otherNumAtRisk":33},{"id":"EG001","title":"4 mg LY3502970 QD","description":"4 mg LY3502970 administered orally QD, Day 8 to Day 15","deathsNumAffected":0,"deathsNumAtRisk":30,"seriousNumAffected":0,"seriousNumAtRisk":30,"otherNumAffected":15,"otherNumAtRisk":30},{"id":"EG002","title":"8 mg LY3502970 QD","description":"8 mg LY3502970 administered orally QD, Day 15 to Day 22.","deathsNumAffected":0,"deathsNumAtRisk":30,"seriousNumAffected":0,"seriousNumAtRisk":30,"otherNumAffected":13,"otherNumAtRisk":30},{"id":"EG003","title":"16 mg LY3502970 QD (Fasted)","description":"16 mg LY3502970 administered orally QD (fasted).","deathsNumAffected":0,"deathsNumAtRisk":28,"seriousNumAffected":0,"seriousNumAtRisk":28,"otherNumAffected":18,"otherNumAtRisk":28},{"id":"EG004","title":"16 mg LY3502970 QD (Fed)","description":"16 mg LY3502970 administered orally QD (fed).","deathsNumAffected":0,"deathsNumAtRisk":27,"seriousNumAffected":0,"seriousNumAtRisk":27,"otherNumAffected":12,"otherNumAtRisk":27}],"otherEvents":[{"term":"Abdominal distension","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":7,"numAffected":6,"numAtRisk":33},{"groupId":"EG001","numEvents":3,"numAffected":2,"numAtRisk":30},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":30},{"groupId":"EG003","numEvents":5,"numAffected":4,"numAtRisk":28},{"groupId":"EG004","numEvents":3,"numAffected":3,"numAtRisk":27}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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